Share Facebook
Crohn's Disease Forum » Books, Multimedia, Research & News » Research into MAP as the cause of Crohn's


 
04-05-2016, 01:17 PM   #121
Mattie
Senior Member
 
Mattie's Avatar
 
Join Date: Jun 2013
Thanks. From what I understand about 'named patient basis' programmes, the patient has to be seriously ill and have exhausted all other available forms of treatment. An application to be considered under the named patient programme will most probably have to be made by the doctor and not the patient? Am I correct here? If so, can anyone hazard a guess as to the earliest date
the vaccine, provided it proves to be the answer we are all looking for, could be made available to those who don't fall into the above category?
04-05-2016, 04:05 PM   #122
Zim
 
Zim's Avatar
 
Join Date: Feb 2016
Location: New York

My Support Groups:
can anyone hazard a guess as to the earliest date
the vaccine, provided it proves to be the answer we are all looking for, could be made available to those who don't fall into the above category?
From the same source:
In addition, following the demonstration of safety and efficacy, it is anticipated that the Vaccine technology would be licenced to a pharmaceutical company to make it available to all who need it through health services worldwide -as part of this, larger Phase 3 trials inviting wider participation would be expected.
I understand it as such: vaccine (or placebo of course, 50/50..) will be available to anyone who is willing to participate and is eligible for phase 3 trial. If phase 2 finishes by the end of 2017, we could be optimistic enough to expect phase 3 to start in the beginning of 2018.

That's why i said "happy new year 2018!" =)

Not sure, but common sense says that for ethical reasons those who got in placebo group still should be vaccinated, but later, after demonstration of the undoubtful fail of placebo for this certain patient.
__________________

http://crohnsMAPvaccine.com/

04-05-2016, 04:24 PM   #123
Mattie
Senior Member
 
Mattie's Avatar
 
Join Date: Jun 2013
Thanks a lot Zim. Very useful.
05-01-2016, 08:19 PM   #124
irishgal
Senior Member
 
irishgal's Avatar
 
Join Date: May 2015

My Support Groups:
New post at The Crohn's Infection by Dr. Robert Click, of Dietzia fame. Dietzia seems to be a probiotic combating the effects of MAP in cattle, and may have human applicability. An intro summarizing the published research and giving some background can be found here:

http://thecrohnsinfection.org/whats-new/

Would be so amazing if this worked! Very excited to see if there will be trials starting in the future.
__________________
Currently on: Anti-MAP therapy and loving life! Full remission since Jan 2015. Clarithromycin, rifampin and low dose naltrexone. (Levofloxicin had too many side effects so discontinued after 5 months.) Resources on human MAP and Crohn's here: HumanPara.org.

Past (failed) Treatments: Remicade, Humira, Prednisone, Pentasa, Azulfadine, Lialda, No gluten/dairy/sugar/coffee or processed food in general. Flagyl worked but not long term.
05-06-2016, 04:11 PM   #125
Scared1
Senior Member
 
Join Date: Apr 2016
New post at The Crohn's Infection by Dr. Robert Click, of Dietzia fame. Dietzia seems to be a probiotic combating the effects of MAP in cattle, and may have human applicability. An intro summarizing the published research and giving some background can be found here:

http://thecrohnsinfection.org/whats-new/

Would be so amazing if this worked! Very excited to see if there will be trials starting in the future.
Thanks Irishgal!
05-08-2016, 07:11 PM   #126
Scared1
Senior Member
 
Join Date: Apr 2016
http://www.healio.com/gastroenterolo...-crohns-binary

Thought this was interesting - one statement said that ileal and colonic crohns are as distinct as crohns is from uc based on these three genes...so do all crohn's sufferers have at least one of these genes?
05-16-2016, 06:09 PM   #127
Scared1
Senior Member
 
Join Date: Apr 2016
https://m.youtube.com/watch?v=7x3lq8QEg5g

This is perfect
06-18-2016, 07:53 AM   #128
JMC
Senior Member
 
JMC's Avatar
 
Join Date: Sep 2011
Location: London, United Kingdom
It's interesting that this approach is effective against "16 MAP clinical strains and 19 other mycobacteria"

RHB-104 triple antibiotics combination in culture is bactericidal and should be effective for treatment of Crohn’s disease associated with Mycobacterium paratuberculosis


http://gutpathogens.biomedcentral.co...099-016-0115-3

Mycobacterium avium subspecies paratuberculosis (MAP) has been implicated as an etiological agent of Crohn’s disease (CD), a debilitating chronic inflammatory bowel disease. Clarithromycin (CLA), clofazimine (CLO), rifabutin (RIF) and other antibiotics have been used individually or in combinations with other drugs to treat mycobacterial diseases including CD. The treatment has varied by regimen, dosage, and duration, resulting in conflicting outcomes and additional suffering to the patients. RHB-104, a drug formula with active ingredients composed of (63.3 %) CLA, (6.7 %) CLO, and (30 %) RIF, has been recently subjected to investigation in an FDA approved Phase III clinical trial to treat patients with moderate to severe CD. In this study, we determined the efficacy of RHB-104 active ingredients against MAP strains isolated from the blood, tissue, and milk of CD patients. Based on fluorescence quenching technology using the Bactec MGIT Para-TB medium, we determined the minimum inhibitory concentration (MIC) of CLA, CLO, RIF individually and in dual and triple combinations against 16 MAP clinical strains and 19 other mycobacteria.
06-18-2016, 02:05 PM   #129
Scared1
Senior Member
 
Join Date: Apr 2016
It's interesting that this approach is effective against "16 MAP clinical strains and 19 other mycobacteria"

RHB-104 triple antibiotics combination in culture is bactericidal and should be effective for treatment of Crohn’s disease associated with Mycobacterium paratuberculosis


http://gutpathogens.biomedcentral.co...099-016-0115-3

Mycobacterium avium subspecies paratuberculosis (MAP) has been implicated as an etiological agent of Crohn’s disease (CD), a debilitating chronic inflammatory bowel disease. Clarithromycin (CLA), clofazimine (CLO), rifabutin (RIF) and other antibiotics have been used individually or in combinations with other drugs to treat mycobacterial diseases including CD. The treatment has varied by regimen, dosage, and duration, resulting in conflicting outcomes and additional suffering to the patients. RHB-104, a drug formula with active ingredients composed of (63.3 %) CLA, (6.7 %) CLO, and (30 %) RIF, has been recently subjected to investigation in an FDA approved Phase III clinical trial to treat patients with moderate to severe CD. In this study, we determined the efficacy of RHB-104 active ingredients against MAP strains isolated from the blood, tissue, and milk of CD patients. Based on fluorescence quenching technology using the Bactec MGIT Para-TB medium, we determined the minimum inhibitory concentration (MIC) of CLA, CLO, RIF individually and in dual and triple combinations against 16 MAP clinical strains and 19 other mycobacteria.
Hi JMC - that is very interesting. The link won't work for me though, I think it may be my computer....any update on the vaccine status timeline? I keep checking and it is not updated. I am so anxious to know that at least some of the trials have begun!

I am also following the Qu SSI - I think the combination of the two can be a powerful way to clear out this infection in the body....
06-18-2016, 07:12 PM   #130
irishgal
Senior Member
 
irishgal's Avatar
 
Join Date: May 2015

My Support Groups:
I also found this article very interesting in that they tried each antibiotic alone and each of the combinations of just two together, and found that the Mean Inhibitory Concentration was the lowest when the three were used together. They have a synergistic effect together. I guess the refrain of "we're all stronger together" applies not only to us, but to our antibiotics as well!
06-18-2016, 11:57 PM   #131
Scared1
Senior Member
 
Join Date: Apr 2016
Finally got it to open! This is very interesting - the Redhill trial is still going on until November, correct? Based on the info I see at ClinicalTrials.gov. But if this is any indication - this would be great. The only thing I am concerned about is that the results of the Redhill can be skewed - I mean, I am hoping they enroll those that are positive for MAP, kinda of like SSI Qu biologics - they have to have positive AIEC cultures to be enrolled based on the website criteria (or maybe I am mistaken)? Whatever the case, I am so anxious to see the results of this!
06-19-2016, 06:45 AM   #132
JMC
Senior Member
 
JMC's Avatar
 
Join Date: Sep 2011
Location: London, United Kingdom
I keep checking and it is not updated. I am so anxious to know that at least some of the trials have begun!
I don't know when this will be completed, I have asked, but not received a reply. Please contact Amy or John Hermon-Taylor directly so they know you are interested.
06-20-2016, 10:17 AM   #133
Kaevata
 
Kaevata's Avatar
 
Join Date: Mar 2013
Location: Bedford, United Kingdom
Thanks for all this information.

It has made me cast my mind back to Ireland 1976 living on my father-in-laws farm for a year and drinking unpasteurized milk.

The old man got TB from the cattle and I suffered the worst bout of food poisoning ever while I was living there and I was never quite right after that.
We returned to the UK and in 1984 I was diagnosed with IBS then finally Crohn's.

Have to wonder if that milk had MAP in it but I did have three maternal aunts with Crohn's, all who drank unpasteurized farm milk in the 1930s onward.

06-20-2016, 10:39 AM   #134
irishgal
Senior Member
 
irishgal's Avatar
 
Join Date: May 2015

My Support Groups:
Yikes Kaevata! Sorry you have CD. Sounds like your family has history of Crohn's so there may be some genetic susceptibility there. My entire family is littered with autoimmune diseases as well, so I think I probably have the mutations they look for in CD. Plus to compound things in your case, unpasteurized milk was probably doing you no favors. From what you say, sound like something in that milk triggered your disease. I was triggered by a bad stomach flu, and I've heard of others who can pinpoint the time when their disease began to a solid event. It would make sense with the MAP theory of CD at least.

I've also heard speculation that IBS may really just be pre-Crohn's, so it's interesting that you had IBS which escalated into CD. Hope your disease is under control now!
06-20-2016, 11:04 PM   #135
Scared1
Senior Member
 
Join Date: Apr 2016
http://crohnsmapvaccine.com/vaccine/#

Looks like they updated the MAP vaccine timeline with more detail than before - this is great!
06-21-2016, 12:41 PM   #136
Scared1
Senior Member
 
Join Date: Apr 2016
http://crohnsmapvaccine.com/vaccine/#

Looks like they updated the MAP vaccine timeline with more detail than before - this is great!
But I just noticed that the human trial piece got pushed out until 2018!:-(
06-21-2016, 12:55 PM   #137
JMC
Senior Member
 
JMC's Avatar
 
Join Date: Sep 2011
Location: London, United Kingdom
But I just noticed that the human trial piece got pushed out until 2018!:-(
I think the more interesting date(s) are when the trial(s) will actually start. I would be very happy to see the phase I trial start this year. Once it begins, the end date will become clearer. Phase IIa is also currently unfunded, but I would not say that is a big concern right now.
06-21-2016, 12:57 PM   #138
Scared1
Senior Member
 
Join Date: Apr 2016
I think the more interesting date(s) are when the trial(s) will actually start. I would be very happy to see the phase I trial start this year. Once it begins, the end date will become clearer. Phase IIa is also currently unfunded, but I would not say that is a big concern right now.
Yes, I agree. I just want at least some data presented -maybe then everyone will get on the bandwagon funding wise. For Qu Biologics, it took them a while to get the word out but one you have some data to show that it works, I think that will be a huge step forward!
06-22-2016, 09:09 AM   #139
eleanor_rigby
Senior Member
 
Join Date: Aug 2012
Location: Cheshire, England, United Kingdom

My Support Groups:
delete
06-22-2016, 09:30 AM   #140
Scared1
Senior Member
 
Join Date: Apr 2016
Redhill update! http://www.reuters.com/article/idUSFWN19E01X

And a new interesting article about Johne's and Crohn's:
http://www.independent.ie/business/f...-34817140.html
07-27-2016, 07:40 PM   #141
Scared1
Senior Member
 
Join Date: Apr 2016
http://www.bionapcfa.com/2016/07/red...s-drug-is.html

Very nice article - but it seems the redhill antibiotic would be around $1500 a month if it does work (and fingers crossed it will:-)
07-27-2016, 10:15 PM   #142
irishgal
Senior Member
 
irishgal's Avatar
 
Join Date: May 2015

My Support Groups:
This isn't from RedHill, though it's interesting. I think this is a guy who evaluates pharma companies, so he's just speculating on the cost and what the market could bear.
07-28-2016, 04:47 PM   #143
Scared1
Senior Member
 
Join Date: Apr 2016
This isn't from RedHill, though it's interesting. I think this is a guy who evaluates pharma companies, so he's just speculating on the cost and what the market could bear.
Yes, I saw that it is from an analyst discussing the valuation of Redhill. :-) But made me wonder - cost-wise what it would be, and if it turns out well - which I really am certain it will - if insurance will cover it. Same with the MAP vaccine...either way, I am soo looking forward to the results!
07-28-2016, 06:17 PM   #144
irishgal
Senior Member
 
irishgal's Avatar
 
Join Date: May 2015

My Support Groups:
Scared - guessing it will be priced based on other non-generic Crohn's meds, but it will be interesting to see if the price may be lower since the active ingredients in this pill are available in generics. Certainly, this pill has big advantages in combining them (from a previous study about how they're synergistic) and clofaz isn't really available in the US, but people are basically using these three drugs now, just seperately. I wonder if that will lower the cost some? The RedHill pill may also have some secret non-active ingredient that does something critical, either for absoprtion, buffering, etc which is why it may work better than the generics. Plus, the dosage is highly adaptable in the RedHill pill (since the daily dose is 10 pills) so it could be tapered to the individual based on body weight. A huge advantage if it gets approved for pediatric cases.Much harder to do that with the generics since some only come in standard dosages.

Also, if the FDA approves it for CD, I'm guessing that most likely insurance will cover it. I think it's the off label stuff that's harder to get covered, but once it's approved, the insurance usually covers all of the other standard CD treatments. Why not this one too?

Not sure about the Vaccine. If it goes through the US FDA application process as an approved CD treatment, then probably that would be covered too. I think the government approval is key for insurance coverage.
07-28-2016, 11:10 PM   #145
Scared1
Senior Member
 
Join Date: Apr 2016
http://www.enterome.fr/site/eb8018-ibd210/

I think this is so interesting- not regarding MAP but AEIC and the drug they are doing almost mirrors the logic behind the MAP vaccine initiative I think...very exciting though
07-28-2016, 11:15 PM   #146
Scared1
Senior Member
 
Join Date: Apr 2016
Here is their pipeline summary:

http://www.enterome.fr/site/#pipeline
07-29-2016, 05:11 AM   #147
irishgal
Senior Member
 
irishgal's Avatar
 
Join Date: May 2015

My Support Groups:
Very interesting Scared. Plus, it's another venture that Nestle is involved in. Takeda and Johnson & Johnson are partners as well. The microbiome research is drawing some big names. It will be interesting to see how this AIEC theory works in CD.
07-29-2016, 08:11 AM   #148
eleanor_rigby
Senior Member
 
Join Date: Aug 2012
Location: Cheshire, England, United Kingdom

My Support Groups:
http://www.enterome.fr/site/eb8018-ibd210/

I think this is so interesting- not regarding MAP but AEIC and the drug they are doing almost mirrors the logic behind the MAP vaccine initiative I think...very exciting though
When does this hit trials?
08-22-2016, 09:43 AM   #149
Scared1
Senior Member
 
Join Date: Apr 2016
Just saw this publication but can't seem to find the actual paper!

Increased Milk Consumption but Decreased Risk of Crohn's Disease (CD): Critical Evidence Negated Causative Role of Mycobacterium avium Subspecies paratuberculosis (MAP) in CD
08-22-2016, 09:44 AM   #150
Scared1
Senior Member
 
Join Date: Apr 2016
When does this hit trials?
Hi Eleanor, I am not sure - but I do think based on the video's I have watched - 3-4 yearish...
Reply

Crohn's Disease Forum » Books, Multimedia, Research & News » Research into MAP as the cause of Crohn's
Thread Tools


All times are GMT -5. The time now is 05:10 AM.
Copyright 2006-2017 Crohnsforum.com